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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8-11 July 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Version / remarks:
Took this guideline into consideration
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009 version
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
GLP compliance:
yes
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
Sample was tested as received
Mass median aerodynamic diameter:
ca. 10.378 µm
Geometric standard deviation:
ca. 0.08
Remarks on result:
other: Average results are calculated from the entirety of the data and are not simple arithmetic means
Key result
Percentile:
D10
Mean:
ca. 2.47 µm
St. dev.:
0.04
Key result
Percentile:
D50
Mean:
ca. 9.566 µm
St. dev.:
0.075
Key result
Percentile:
D90
Mean:
ca. 40.672 µm
St. dev.:
0.398
No.:
#1
Size:
< 10 µm
Distribution:
ca. 51.99 %

During the method development phase of the analysis trials were conducted using both the dry powder module (DPM) and the small volume (wet) module (SVM). The SVM trials were conducted using water as the dispersant. The results of these trials indicated that the most appropriate test and material parameters to obtain the optimum measurements were. Using the identified parameters, the particle size was analysed over the range 0.02 µm to 2000 µm.

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Conclusions:
Average MMAD for the substance as supplied was determined at 10.378 μm, with a standard deviation of 0.08 μm using a laser diffraction method.
Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.
Executive summary:

The Mass Median Aerodynamic Diametre of a sample of the substance was determined by Laser Diffraction Particle Analysis at 10.378μm with a standard deviation of 0.08 μm (0.8%). Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%.

Description of key information

Average MMAD for the substance as supplied was determined at 10.378 μm, with a standard deviation of 0.08 μm using a laser diffraction method.

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Additional information